Inflatable implants such as those used in breast reconstruction have been in use for many years. Such implants include at least one and sometimes two soft and pliable members or lumens. The lumens are filled with various materials including saline, silicone gel and the like. For example, one of my earlier U.S. Pat. No. 4,944,749 which issued on Jul. 31, 1990 discloses an implant and inflating construction, which includes inner and outer membranes each having a separate valve. As disclosed therein, the outer membrane contains a viscous gel and the inner membrane is inflated by saline through a removable soft filling tube which passes through the valves.
Concerns over the use of silicone implants led to improved valves as disclosed in my U.S. Pat. No. 5,507,808 for a filling tube and valve construction. As disclosed therein, the valve comprises a short semi-rigid tube that surrounds an opening in a membrane and extends inwardly on the membrane and into the chamber. The semi-rigid tube defines a passageway extending therethrough and also defines a relatively small reservoir which opens into the passageway. A filling tube comprises a soft and flexible length of tubing and a solid portion having an outer diameter which is slightly larger than the inner diameter of the semi-rigid tube and is stretchable longitudinally to reduce its outer diameter to facilitate passage through the semi-rigid tube. As disclosed, the solid portion is adapted to sealingly engage the semi-rigid tube upon relaxation thereof.
The availability of improved valves and reduced concern about the use of silicone gel have led to an increased interest in silicone filled implants. For example, an improved breast prosthesis is disclosed in my U.S. Pat. No. 6,183,514 for a self-positioning breast prosthesis. As disclosed therein, a dual lumen gravity oriented implant includes inner and outer closed envelopes of a medical grade elastomer. The outer closed envelope is generally tear shaped and filled with silicone gel. The inner envelope which is filled with a saline solution is disposed in a lower portion of the prosthesis and returns the prosthesis to its predetermined orientation when an individual to whom the prosthesis is implanted is in a standing or sitting position.
The disclosures in my above-identified patents are incorporated herein in their entirety by reference.
It is now believed that there may be a significant market for an improved breast prosthesis in accordance with the present invention. It is believed that there should be a significant market for such implants, which provide a more natural feel and relatively light weight. The implants in accordance with the present invention are essentially gel or silicone implants and have all of the advantages of such implants. However, such implants provide for miner adjustments in size and on some tissue expansion without detracting from the advantages of a gel filled implant. In addition, the improved prosthesis in accordance with the present invention allows moderate tissue expansion and final size adjustment.